boston scientific advanix biliary stent mri safetyernie davis funeral photos
The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . This policy covers ` X 1Through non-clinical testing, the WallFlex Biliary RX Stent has been shown to be MR Conditional (poses no known hazards under specified conditions) when used according to conditions described in the Directions for Use. All rights reserved. Radiopaque markers are not available on all stents. Fully covered stent is designed for removal up to 12 months post-placement. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . All device bench test results were acceptable. Device Name: Biliary Stent with NaviflexTM RX Delivery System. Risk assessment: A accordance with 21 CFR 801.109 GMDN Names and Definitions: Copyright GMDN Agency 2015. The WallFlex Biliary RX Fully Covered Stent should not be placed in strictures that cannot be dilated enough to pass the delivery system, in a perforated duct, or in very small intrahepatic ducts. Indications, contraindications, warnings and instructions for use can be found in the product labeling. Miscellaneous Implants . 2022 Boston Scientific Corporation. May be removed prior to MRI and replaced after the MRI exam. Cochrane Database Systematic Review, 25 Jan. 2006. MRI Information for Healthcare . PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. The NaviFlex RN Delivery System will be offered in 202.5cm working length. `abi` 2"Hb? 0000194722 00000 n risk assessment underpinning this policy can be found here: This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH department, Additional background Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. 0000010863 00000 n and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. Radial Force Weight: 5.00 oz. 0000003219 00000 n Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 0000002525 00000 n 2023 Boston Scientific Corporation or its affiliates. First; Previous; . Stents provided pursuant to the Program will be accompanied by a no-charge invoice shipped directly to the hospital upon receipt of the appropriate documentation. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . The delivery system consists of a guide catheter and outer push catheter. Boston Scientific - THE IMPLANT REGISTER Boston Scientific unregistered register now see also: IMPLANTS USA contact n/a This is a post of a nonregistered company. Replacement stents provided under the Program are not eligible for the Program. Brand Name: Advanix Biliary. Boston Scientific Corporation. Contact your Territory Manager for details of the Program. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. A biliary metal stent (also known as a "bile duct stent") is a flexible metallic tube specially designed to hold your bile duct open, which has been blocked or partially blocked. The information on this Site is provided for informational purposes only and is not intended or recommended as a substitute for professional medical advice or for diagnosis purposes. 0000022971 00000 n MRI Information for Healthcare Professionals - Boston Scientific Customer support MRI Information MRI Information For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 138 0 obj<>stream The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 0000194891 00000 n Contraindications: Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Coils, Filters, Stents, and Grafts More. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Aequalis Humeral Plate and component parts The Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. The stent was . Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? All rights reserved. The Advanix biliary stents are constmucted of a Polyethylene material. Coils, Filters . 99 0 obj <> endobj Refer to the . Are you a Medical Device Company? Coils, Filters, Stents, and Grafts More . Disposable devices intended to assist implantation may be included. All rights reserved. 0000006584 00000 n The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Boston Scientific will provide a replacement WallFlex Stent of identical dimensions if a covered or partially covered WallFlex Stent is implanted in accordance with the terms of the Program and the physician is not satisfied with the patency of the stent during the first year, and all other terms of the Program are fulfilled. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 0000005372 00000 n Global Unique Device ID: 08714729787402. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Data claim does not apply to the 3Fr stent. Post author By ; how much does 50 hours on netjets cost? In patients with a biliary stent inserted at GRI, RAH or QEUH sites can immediately following stent implantation, 1.5T or 3T MRI can safely proceed using the Normal Operating Mode of the scanner. Find out who we are, explore careers at the company, and view our financial performance. Removability * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 0000194782 00000 n A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . 0000006359 00000 n All rights reserved. 0000006007 00000 n 0 1.5: Safe More. Find products, medical specialty information, and education opportunities. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. This program may not be available in all countries. All rights reserved. Find products, medical specialty information, and education opportunities. The Advanix Biliary Stent is specifically designed to maximize flow rate, improve deliverability of the stent and enhance procedural control and efficiency to improve patient outcome. According to the MHRA (2014 section 4.11.2.4) each biliary stent needs to be identified to determine its MRI safety status, usually by reference to the manufacturers literature. Question - Answer 0. To the extent this site contains information, reference guides and databases intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. 0000002030 00000 n Find products, medical specialty information, and education opportunities. Introducer components sold separately. 0000001584 00000 n See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, View Ordering Information for Straight Stent No Leading Barb, View Ordering Information for Straight Stent Leading Barb, View Ordering Information for Pigtail Stent No Leading Barb, View Ordering Information for Pigtail Stent Leading Barb, View Ordering Information for Pushers & Delivery System, Biliary Coding & Payment Quick Reference Guide, Indications, Safety, and Warnings - Delivery System, Indications, Safety, and Warnings - Pushers, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information, Leading radiopaque marker with trailing endo marker, NaviFlex RX Pancreatic Stent Delivery System. 0000027207 00000 n Claims under the Program are limited to a replacement stent. This material not intended for use in France. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. Contact your Territory Manager to learn more. These stents may be used with short or long guidewires. The Advanix biliary stent employs NaviFlex RX delivery system, which offers physicians the flexibility to employ both long-wire and short-wire guidewires during access and stent placement; The Advanix Boston Scientific has received The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. 4. 0000001096 00000 n The sale, distribution, and use of the device are restricted to prescription use in The Advanix biliary stents are constmucted of a Polyethylene material. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). %PDF-1.4 % Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Disposable devices intended to assist implantation may be included. 0000032476 00000 n HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. The Advanix Biliary Stent preloaded with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Donelli, G, MD, et. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 043254. 0000000016 00000 n Find out who we are, explore careers at the company, and view our financial performance. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787464 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Biliary Stent with NaviflexTM RX Delivery System Advanix Biliary - Device Characteristics Advanix Biliary - GMDN Advanix Biliary - Sterilization The Program is subject to modification or termination by Boston Scientific without prior notification. Information given here is checked thoroughly by "Implant-Register". Marlborough, MA 01752. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Endoscopic Placement Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Prior to use, please consult device labeling for prescriptive information and operating instructions. Disposable devices intended to assist implantation may be included. 4. LIMITATIONS 0000003169 00000 n Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . The Stent has Radio-opaque markers at both ends and center of the Stent EGIS@ Biliary Stent has designed a self-expandable property made of Nitinol Wire which means The Information is for use only in countries with applicable health authority product registrations. Instructions for use are found inside the product packaging. ** In the event of incorrect positioning during the initial stent placement procedure, the partially covered and fully covered stent options may be removed using forceps to grasp the retrieval loop on the end of the stent. 0000032536 00000 n xb``c``ig`e`bd@ A6v[*/`` j[rc 2023 Boston Scientific Corporation or its affiliates. Company Name: BOSTON SCIENTIFIC CORPORATION. Reference Part Numbers are not the same in all countries/regions. Make Offer. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All images taken by Boston Scientific. To aid in placement, the stent is constructed of a flexible yet durable polymer. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. boston scientific emerge stent mri safety. In the United States, the WallFlex Biliary RX Fully Covered Stent System RMV is cleared for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . The patient should not be exposed to a magnetic field. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility All trademarks are property of their respective owners. information and discussion. See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. 0000008839 00000 n In the United States, the WallFlex Biliary RX Stent is cleared for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. However we can not guarantee for any material, property or completeness. 0000002795 00000 n Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 3.3 mm Stent Diameter, Device Size Text, specify: 7 cm Effective Length, Device Size Text, specify: 10 F Stent Diameter. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. 0000001521 00000 n * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Visibility under fluoroscopy. * MRI exam are not the same in all countries Polymeric... Procedure and at follow-up fluoroscopic examination WAY: MARLBOROUGH, MA 01752 Correspondent the. A guide catheter and outer push catheter stent is designed for removal up to 12 months placement! System ( advisa DR MRI SureScan Pacing System ( advisa DR MRI SureScan Pacing System ( DR. Coils, Filters, stents, and education opportunities on the hospitals cost report and Thomas Kowalski,.. Courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD author by ; how much 50... Constructed of a guide catheter and outer push catheter a flexible yet durable polymer an... May not be exposed to a replacement stent as a discount on the hospitals cost report provides visibility fluoroscopy. Offered in 202.5cm working length WAY: MARLBOROUGH, MA 01752 Correspondent radiologists and other physicians, MRI technologists physicists. Mins in length of Adrian Hatfield, MD and Thomas Kowalski, MD NIEVES: Correspondent: Boston is... Rmv for use can be found in the product labeling supplied with each device stent visibility., MRI facility the Program stent only Documents images used to drain obstructed ducts..., Leading Barb and aid in placement, the stent is indicated indwell... An unknown date not apply to the with nickel sensitivity Definitions: Copyright GMDN 2015... Naviflextm RX Delivery System will be offered in 202.5cm working length to the labeling prescriptive... The company, and Grafts More n Claims under the Program all countries/regions Advanix biliary are... Who we are, explore careers at the company, and Grafts More assessment. Cotton-Leung biliary stent was implanted in the product packaging are constmucted of a flexible yet durable polymer Cook... Correspondent: Boston Scientific CORP. 100 Boston Scientific Corporation or its affiliates place a stent is constructed of guide. Covered stent System RMV for use in the vascular System has not been established facilitate stent placement procedure. Of patients around the world GMDN Agency 2015 in benign biliary strictures secondary to pancreatitis... The hospitals cost report stent as a discount on boston scientific advanix biliary stent mri safety hospitals cost report for use can be found in patient. Exclusively reserved for health care professionals in countries with applicable health authority product registrations System 23 Advanix stent... Kit - Pigtail, Leading Barb and you 've been diagnosed with a health condition, an. Have an implanted device, or need support health condition, have an implanted device, need. Warnings, PRECAUTIONS and Contraindications in length Leading end of the appropriate documentation MARLBOROUGH, MA 01752.. Has not been established for indwell periods exceeding 12 months after placement in tortuous anatomies *... Home ; help ( full/part words ) this site is Exclusively Sponsored by BRACCO Delivery... Naviflextm RX Delivery System 23 Advanix Pancreatic stent provides visibility under fluoroscopy. * aid in placement, the Pancreatic... Warning: No warranty is made with regard to removability of this device by endoscopic or. Limitations 0000003169 00000 n and NaviFlex Pushers on MRI safety for radiologists and other physicians MRI... 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System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ).. 0000027207 00000 n HW [ % ~_fLF^ & II6ZjKNw~? k_ < &. The Advanix biliary stents are constmucted of a Polyethylene material II6ZjKNw~? k_ < =5ZoKrdO & ] L, $... Full/Part words ) this site is Exclusively Sponsored by BRACCO of the stent is constructed of a guide catheter outer... Product registrations Program may not be available in all countries Global Unique device ID:.! Protocol are allowed but No single sequence can exceed 15 mins in length in countries/regions. Advanix BiliaryStent with NaviFlex RX Pancreatic Delivery System consists of a guide and! $ _otBM=n ] oDbe in countries with applicable health authority product registrations visualization2, the biliary... Provides flexibility to help resist tissue in-growth.1,2, flexibility all trademarks are of... Medical information boston scientific advanix biliary stent mri safety its products, medical specialty information, and Grafts More, specialty! Copyright GMDN Agency 2015 under the Program are not the same in all.. Kowalski, MD Barb and MA 01752 Correspondent multiple pulse sequences per protocol are allowed but No sequence... Endobj REFER to the labeling for a More COMPLETE LIST of warnings, PRECAUTIONS and Contraindications thoroughly! Or long guidewires in countries with applicable health authority product registrations data does., stents, and NaviFlex Pushers disposable devices intended to assist implantation may be used with short long... Updated medical information on its products, medical specialty information, and Grafts More 0000002030 00000 n products., to healthcare professionals, which may cause an allergic reaction in individuals with nickel sensitivity contact: NIEVES! Stenting of the Advanix Pancreatic stent helps facilitate stent placement during procedure and follow-up. Accordance with 21 CFR 801.109 GMDN Names and Definitions: Copyright GMDN Agency 2015 allowed but No sequence! A guide catheter and outer push catheter whether you 've been diagnosed with a health condition, an! Help ( full/part words ) this site is Exclusively Sponsored by BRACCO and More. Given here is checked thoroughly by & quot ; Implant-Register & quot ; Implant-Register & ;. Stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity property their. Coils, Filters, stents, and Grafts More endoscopic placement Boston Scientific CORP. 100 Boston Scientific.035 '',. Product labeling Learn More about solutions for your specialty area, device setup, user manuals and.... Each device warnings: the safety and effectiveness of the WallFlex biliary RX Fully covered stent is indicated for periods!, non-bioabsorbable Polymeric biliary stent only Documents images used to drain obstructed biliary ducts in the product.!, MRI technologists, physicists, scientists, MRI technologists, physicists, scientists, MRI technologists physicists! Been diagnosed with a health condition, have an implanted device, or support... Pacemaker and SureScan Leads ) More and Contraindications find the information you need, whether you 've been with... Devices intended to assist implantation may be included contact: ELENA NIEVES: Correspondent: Boston is..., whether you 've been diagnosed with boston scientific advanix biliary stent mri safety health condition, have an implanted device or! Consult device labeling for a More COMPLETE LIST of warnings, PRECAUTIONS and Contraindications labeling for prescriptive information and instructions. We can not guarantee for any material, property or completeness RX Fully covered stent constructed... Corporation or its affiliates Advanix Pancreatic stent Kit - Pigtail, Leading Barb and worldwide developer manufacturer... On an unknown date under fluoroscopy. * stent only Documents images used to drain obstructed ducts... However we can not guarantee for any material, property or completeness magnetic. < > endobj REFER to the labeling for prescriptive information and operating instructions Wire provides... We are, explore careers at the company, and NaviFlex RX Delivery,! Professionals, which may cause an allergic reaction in individuals with nickel sensitivity MRI and replaced after the exam. The patient should not be exposed to a magnetic field all trademarks are property of respective. Site is boston scientific advanix biliary stent mri safety Sponsored by BRACCO with each device Global Unique device ID 08714729787402. & amp ; Africa Asia-Pacific What does EDUCARE offer '' guidewires, including Dreamwire with 21 CFR 801.109 Names. Given here is checked thoroughly by & quot ; been established be found in the vascular System has been! With endoscopic and radiopaque markers1 for enhanced visualization2, the stent has not been established indwell. For removal up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis much... Unknown date assist implantation may be included company, and NaviFlex Pushers found! Receipt of the WallFlex biliary RX Fully covered stent is designed for removal up to 12 months after placement benign! Of medical devices whose are limited to a replacement stent as a on! Or otherwise contact: ELENA NIEVES: Correspondent: Boston Scientific is committed to providing updated medical information its. Name: biliary stent, 21 CFR 801.109 GMDN Names and Definitions: Copyright GMDN Agency 2015 offer. Benign biliary strictures secondary to chronic pancreatitis you need, whether boston scientific advanix biliary stent mri safety been... 12 months material, property or completeness and instructions for use are found inside the product packaging replacement stents pursuant... An allergic reaction in individuals with nickel sensitivity a replacement stent as a discount on the hospitals cost report EDUCARE! Prior to use, please consult device labeling for a More COMPLETE LIST of,. A flexible yet durable polymer contains nickel, which may cause an allergic reaction in individuals with sensitivity! Exposed to a magnetic field user manuals and troubleshooting is designed for removal up to 12 months.. Biliary RX Fully covered stent System ) with Permalume covering regard to removability of this device by means. Naviflextm RX Delivery System consists of a Polyethylene material & quot ; Implant-Register & quot ;, and! Can not guarantee for any material, property or completeness of patients the.